Elettrmedicale 9

The first and second editions of IEC 60601-1 were based on a "philosophy" quite different from the general standard of safety systems E/E/PES IEC 61508; the new edition, the third, albeit remaining substantially different from the IEC 61508, adopts a "new philosophy" that has more points of contact with it, in fact introduces a greater interaction between the manufacturing and laboratory tests, especially, the standard introduces the concept of EP (Essential performance) defined as the "performance" necessary to obtain the absence of unacceptable risks or, if you prefer, the degradation or the lack of EP, which is the condition that can lead to an unacceptable risk.

The philosophy of the new edition of IEC 60601-1 is therefore based more on the risk management, taking into account  a renewed Risk Management File (RMF). In fact, about that, reference is made explicitly to risk management defined in the ISO 14971, to which you must necessarily refer. Basically you can not get an IEC 60601-1 certification, if the medical electro-medical device is not  also compliant with ISO 14971.

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HINTSW - T & T Systems, due to its interdisciplinary expertise, is able to provide the necessary support to the manufacturing industry for the correct definition of the Risk Management File in accordance with IEC 60601-1 and ISO 14971, which is able to establish a proper risk management, to establish the acceptable level of risk, to prove that the residual risk is acceptable.
HINTSW - T & T Systems is also able to provide the necessary support to test and analysis laboratories so that they are unable to properly apply the Risk Management File.

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When electro-medical system is programmable, or if  software modules are implemented on board of the system, this system   is called PEMS (Programmable Electrical Medical System); for these systems, in addition to the general sections of IEC 60601-1,  a specific  "section" is also set for the application , specially defined for the programmable electro-medical systems: the "clause 14". This section incorporates the old Collateral Standard IEC 60601-1-4, that was included in previous editions of the standard.
 

The section 14 of   IEC 60601-1 , in short, is the customization, for the software, of the section 4 of the standard and contains the requirements for the following areas: risk management plan; PEMS development life-cycle; risk management process; specification of requirements; architecture, design and implementation detail; verification & validation of PEMS; changes; requirements for  a PEMS to be added to an IT network.

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The subjects covered by IEC 60601-1, albeit in a very concise manner, deal with some concepts contained in the parts  3/5/6 of the aforementioned general standard IEC 61508, for example: the model "V" of the safety life cycle, or the risk graph with the associated classification parameters.
 
The approach to the safety design of programmable electronic systems (PEMS) is also similar to that of IEC 61508, but the whole third part of the standard (IEC 61508-3) was condensed into less than four pages, which constitute Section 14 of IEC 60601-1 ... Surely the only reading of this section can not make skillfull a constructor to design and develop a compliant PEMS !

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In a particular way, with regard to the section 14 of the Standard (the section dedicated to PEMS), HINTSW - T & T Systems is able to provide, to the manufacturing industry  and  to test and analisys  laboratories   an adequate support for all activities to do in the software development and in the  software risk management process. In this context, the main responsibilities are:

  • General part of the IEC 60601-1 standard for the electronic apparatus, and ISO 14971 for the application of risk management to medical devices:
    • Elettrmedicale 10Risk analisys.
    • Development of risk management file (RMF).
    • Test planning (test protocols).
    • Definition of the risk management process and its schedule.
    • Definition of the acceptable level of risk.
    • Demonstration of the acceptability of the risk.
    • Risk control.
    • Risk reduction.
    • Definition and implementation of risk control measures.
    • Identification of characteristics of a medical device that may have impact on safety.
    • Fault Tree Analysis (FTA) , Failure Mode and Effects Analysis (FMEA).
    • Writing of the risk management report.
    • Development of risk management file (RMF). 
  • Section 14 of IEC 60601-1 related to PEMS:
     
    • Planning and management of the documentation.
    • Planning of the safety life cycle.
    • Risk Management Plan.
    • Development of risk management file and risk management summary.
    • Development and planning of the software life cycle.
    • Definition of the risk management process.
    • Requirements specification.
    • Architecture definition.
    • Design and implementation.
    • Verification and validation activities.
    • Evaluation activities.
    • Planning the editing process
  •  

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